For some subpopulations of patients, including pregnant women, the safety profile of IFN β formulations may provide a particular benefit. Since the approval of intramuscular IFN β-1a, a number of high-efficacy therapies have been approved for MS, though the benefit of these high-efficacy therapies should be balanced against the increased risk of serious adverse events associated with their long-term use. MRI studies show that treatment with IFN β-1a, relative to placebo, reduces T2 and gadolinium-enhancing lesions and gray matter atrophy. In recent years, revisions to MS diagnostic criteria have improved clinicians' ability to identify patients with MS and have promoted the use of magnetic resonance imaging (MRI) for diagnosis and disease monitoring. Moreover, subcutaneous IFN β-1a is associated with an increased incidence of injection-site reactions and neutralizing antibodies compared with intramuscular administration. Patient adherence to treatment is higher with intramuscular IFN β-1a, given once weekly, than with subcutaneous formulations requiring multiple injections per week.
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The pivotal intramuscular IFN β-1a phase III trial published in 1996 was the first to demonstrate that a DMT could reduce accumulation of sustained disability in MS.
Since that time, clinical trials and real-world observational studies have demonstrated the effectiveness of IFN therapies. Recombinant interferon (IFN) β-1b was approved by the US Food and Drug Administration as the first disease-modifying therapy (DMT) for multiple sclerosis (MS) in 1993. These findings have relevance to clinical decision making and medication compliance in MS patient care. In the persistent therapy cohort, less patient-reported disability progression was reported with IM IFNβ-1a treatment than with SC IFNβ-1a, IFNβ-1b, or GA. Difficulties with tolerability were more often reported as a reason for discontinuing subcutaneous (SC) IFNβ-1a than as a reason for discontinuing IM IFNβ-1a, GA, or SC IFNβ-1b. Participants on intramuscular interferon beta-1a (IM IFNβ-1a) and glatiramer acetate (GA) reported the fewest discontinuations based on safety concerns, although GA was associated with reports of higher burden and lower efficacy than other therapies. Discontinuation profiles varied among DMTs. Both unadjusted data and data adjusted for baseline age, disease duration, disability, and sex were evaluated. Participants selected their reason(s) for discontinuation from among 16 possible options covering the categories of efficacy, safety, tolerability, and burden, with multiple responses permitted. Using data from the North American Research Committee on Multiple Sclerosis (NARCOMS) database, this study evaluated participants' reasons for discontinuation of injectable DMTs as well as the relationship between staying on therapy and sustained patient-reported disease progression and annualized relapse rates. Accordingly, the various factors that influence patient persistence with treatment and that can lead some patients to switch medications or discontinue treatment may affect clinical outcomes. “The rapid growth of patient-reported outcomes in clinical research is important progress not only for people living with MS, but for organizations seeking to develop and deliver new therapies to the market that make a real difference in the lives of patients,” said Robert McBurney, PhD, president and CEO of ACP and co-principal investigator for iConquerMS. “We are delighted to partner with EMD Serono to break silos of information and advance the engagement of patients across the entirety of the clinical research process.Injectable first-line disease-modifying therapies (DMTs) for multiple sclerosis (MS) are generally prescribed for continuous use.
Through workshops, focus groups, document reviews and surveys, iConquerMS participants will provide input across all stages of the study. Team members from EMD Serono and iConquer will work together to design endpoints of clinical trials as well as define measures and the relative importance of treatment benefits. “Those of us living with multiple sclerosis have the most valuable understanding of what matters most when it comes to treatment of this condition,” Laura Kolaczkowski, lead patient representative and co-principal investigator of iConquerMS, said in a press release. She called the collaboration “an important opportunity for our collective voices and insights to be heard and to drive real progress in research, drug development, and ultimately in the fight against MS.”
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